enzastaurin in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.

objectives: primary * assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer. * determine the nature and degree of toxicity of this regimen in these patients. secondary * determine the duration of progression-free and overall survival of patients treated with this regimen. * determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen. outline: this is a multicenter study. patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. for all subsequent courses, patients receive enzastaurin hydrochloride once daily on days 1-28. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: a total of 68 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed ovarian epithelial or primary peritoneal carcinoma * recurrent or persistent disease * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * must have ≥ 1 target lesion to assess response * tumors within a previously irradiated field are designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy * must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease * initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment * must meet any 1 of the following criteria for platinum-based therapy: * disease progression during therapy * treatment-free interval after completion of treatment \< 12 months * disease persistence after completion of therapy * ineligible for a higher priority gog clinical trial patient characteristics: * gog performance status 0-1 (for patients who received 2 prior treatment regimens) or 0-2 (for patients who received 1 prior treatment regimen) * absolute neutrophil count ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9 g/dl (transfusions allowed) * creatinine \< 1.5 times upper limit of normal (uln) * bilirubin ≤ 2 times uln * alkaline phosphatase ≤ 3 times uln (5 times uln if liver metastases are present) * ast and alt ≤ 3 times uln (5 times uln if liver metastases are present) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after completion of study treatment * able to swallow tablets * no sensory or motor neuropathy \> grade 1 * no active infection requiring antibiotics * no other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer * no serious systemic disorders that would preclude study compliance, including an abnormal ecg indicative of cardiac disease prior concurrent therapy: * see disease characteristics * recovered from prior surgery, radiotherapy, or chemotherapy * at least 1 week since prior anticancer hormonal therapy * no more than 1 additional cytotoxic regimen for management of recurrent or persistent disease * at least 4 weeks since other prior anticancer therapy, including immunotherapy * at least 30 days since prior investigational drugs * no prior enzastaurin hydrochloride * no prior radiotherapy to \> 25% of marrow-bearing areas * no prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease * no prior treatment that would preclude treatment on this protocol * no concurrent chemotherapy, immunotherapy, or other experimental medications * no concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin * no other concurrent systemic anticancer therapy * no concurrent radiotherapy, including palliative radiotherapy * no concurrent agents that stimulate thrombopoiesis * no concurrent amifostine or other protective reagents * concurrent hormone replacement therapy allowed * concurrent bisphosphonates allowed provided bony metastases are present

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer